Package of Resources for Assisted Contact Tracing: Implementation, Costs, and Effectiveness
- Conditions
- Human Immunodeficiency Virus
- Interventions
- Behavioral: Enhanced implementation packageBehavioral: Standard implementation package
- Registration Number
- NCT05343390
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Brief Summary
Having health workers assist HIV-infected persons with the recruitment and testing of their sexual contacts and biological children is an effective and efficient way of identifying additional HIV-infected persons in need of HIV treatment and HIV-uninfected persons in need of HIV prevention. However, in Malawi, a country with a generalized HIV epidemic, health workers lack the counseling and coordination skills to routinely assist their HIV-infected clients with these services. This study will determine how to help health workers to effectively and efficiently provide these services to their patients through a set of digital capacity-building tools.
- Detailed Description
Voluntary assisted contact tracing (ACT) is an evidence-based approach that efficiently identifies persons in need of HIV treatment and prevention. Malawi, like many countries in sub-Saharan Africa, has adopted ACT policies to support its "95-95-95" targets for HIV testing, treatment, and viral suppression.
However, Malawi's ACT implementation has been poor due to deficits in health worker capacity and clinical coordination. Through preliminary work, our team has 1) developed a set of implementation strategies (theory-based health worker training and continuous quality improvement processes) that address these barriers; 2) packaged these strategies into a blended learning platform that combines digital and face-to-face modalities; and 3) field-tested the package in Malawi with promising preliminary results. In this proposal, the package will be rigorously evaluated in Malawi for implementation, service uptake, and cost-effectiveness outcomes.
Through a two-arm pragmatic cluster randomized implementation trial, the proposed research will address these gaps through three specific aims. Twenty Malawian facilities in two districts will be randomized to receive the blended learning implementation package (enhanced) versus standard implementation package (standard). In the first aim, ACT implementation outcomes will be compared between the enhanced and standard arms. Health worker fidelity to ACT procedures will be assessed through audio-recorded ACT encounters. In the second aim, HIV service uptake outcomes will be compared between the enhanced and standard arms. In the third aim, cost and cost-effectiveness outcomes will be examined.
The findings will offer important insights and innovations into how to bridge the gap between ACT research and practice, a critical step towards achieving the 95-95-95 targets.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 841
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enhanced implementation strategy Standard implementation package digitally guided training and continuous quality improvement Standard implementation strategy Standard implementation package standard training and clinical support Enhanced implementation strategy Enhanced implementation package digitally guided training and continuous quality improvement
- Primary Outcome Measures
Name Time Method HIV self-test kits distributed 1 year after training The number of HIV self-test kits distributed relative to the number of total potential index clients measured per facility per calendar quarter (3-month period)
Contact clients elicited 1 year after training The number of contact clients listed by participating index clients relative to the number of total potential index clients measured per facility per calendar quarter (3-month period)
Index client fidelity assessment 1 year after training Health care workers will be observed counseling actual index clients. The scores on the 15-item index client fidelity assessment will be compared between arms (range 0-100% with higher scores being better)
Contact client fidelity assessment 1 year after training Health care workers will be observed counseling actual contact clients. The scores on the 15-item contact client fidelity assessment will be compared between arms (range 0-100% with higher scores being better)
Contact clients tested 1 year after training The number of contact clients tested relative to the number of total potential index clients measured per facility per calendar quarter (3-month period)
Cost per person living with HIV diagnosed 1 year after training The incremental cost per person living with HIV identified
Contact clients living with HIV identified 1 year after training The number of contact clients living with HIV identified relative to the number of total potential index clients measured per facility per calendar quarter (3-month period)
Index clients who participate in assisted contact tracing 1 year after training The total number of index clients who participate in assisted contact tracing relative to the number of total potential index clients measured per facility per calendar quarter (3-month period)
Cost per contact tested 1 year after training The incremental cost per contact tested
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
Ulongwe Health Centre
🇲🇼Balaka, Malawi
Balaka OPD Health Centre
🇲🇼Balaka, Malawi
Kalembo Health Centre
🇲🇼Balaka, Malawi
Kawinga Dispensary
🇲🇼Machinga, Malawi
Ngokwe health Centre
🇲🇼Machinga, Malawi
Namanolo Health Centre
🇲🇼Balaka, Malawi
Phimbi Health Centre
🇲🇼Balaka, Malawi
Utale Health Centres
🇲🇼Balaka, Malawi
Gawanani Health Centre
🇲🇼Machinga, Malawi
Namandanje Health Centre
🇲🇼Machinga, Malawi
Ntaja Health Centre
🇲🇼Machinga, Malawi
Balaka District Hospital
🇲🇼Balaka, Malawi
Kwitanda Health Centre
🇲🇼Balaka, Malawi
Machinga District Hospital
🇲🇼Machinga, Malawi
Mbonechela Dispensary
🇲🇼Machinga, Malawi
Mposa Health Centre
🇲🇼Machinga, Malawi
Namanja Health Centre
🇲🇼Machinga, Malawi
Nayinunje Health Centre
🇲🇼Machinga, Malawi
Nyambi Health Centre
🇲🇼Machinga, Malawi
Chiendausiku Health Centre
🇲🇼Balaka, Malawi
Mbera Health Centre
🇲🇼Balaka, Malawi
Chikweo Health Centre
🇲🇼Machinga, Malawi
Mahinga Health Centre
🇲🇼Machinga, Malawi
Mkwepere Health Centre
🇲🇼Machinga, Malawi
Mpiri Health Centre
🇲🇼Machinga, Malawi
Nayuchi Health Centre
🇲🇼Machinga, Malawi
Nthorowa Health Centre
🇲🇼Machinga, Malawi
Kankao Health Centre
🇲🇼Balaka, Malawi
Namdumbo Health Centre
🇲🇼Balaka, Malawi
Phalula Health Centre
🇲🇼Balaka, Malawi
Chamba Dispensary
🇲🇼Machinga, Malawi
Mangamba Health Centre
🇲🇼Machinga, Malawi
Nsanama Health Centre
🇲🇼Machinga, Malawi